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- 10) List down 3 different test animals and give samples for which purposes they can be used in testing of a designed biomaterials? 11) What does FDA abbreviation stand for? 12) Order for the below given steps prior to FDA approval ? Controlled clinical trials In vitro testing (“in glass") In vivo testing w/animal models of disease In vivo testing w/healthy animalsWe discussed various assay attributes in class which provide insight into the effectiveness or suitability of a given analytical method. As part of assay development, various attributes were investigated. For each description below, indicate which assay attribute was being evaluated (partial list of attributes include precision, accuracy, specificity, linearity, LOQ/LOD, etc.). The impact of assay temperature and pH on assay results were evaluated to find a suitable range of conditions for the activity assay. Various known concentrations of standard α-AM solutions were evaluated, and the proportionality of the responses were determined. A reference standard of known α-AM (alpha-amylase) concentration was evaluated in triplicate to determine the variability (or scatter) of repeat measurements. Spiked standard of known specific activity and purity was spiked into a sample and the ability for the assay to measure the true biological activity was determined. The impact of various extract…In what ways can you use aseptic technique principles in your daily life to preserve a healthy lifestyle, particularly in light of the CoVID-19 pandemic? Explain in four to five sentences.
- What are the COVID-19 safety guidelines for health care professionals? what are the Saudi Patient Safety guidelines for COVID-19?"Implementation of PAT system in manufacturing of pharmaceuticals results in less validation and IPQC tests"- Explain with reasoning and examples broadly.Drug substances are useful based on their biological activity. Thus, an assay must be developed to ensure that this important function is preserved during purification. There are three major types of biological activity assays including animal model assays, cell-line-derived assays, and in vitro biochemical assays. Please find an example of each (in literature, online, etc.) and briefly Include a reference for each (no particular reference format required, can simply include a web link if easiest).
- Hello! Discuss the advantages and disadvantages of targeted vs mass control using COVID-19. ( if you can also link an article which talks about this it will be much appreciated!) Thank you!A medical technology intern was assigned to the serology section of a clinical laboratory. His supervisor asked him to prepare a 5% red cell suspension, which will be used to run a hemagglutination inhibition assay. The intern, being aware of the importance of preparing the desired concentration of red cells recommended in the assay, considers the factors enumerated on the table below during the sample processing. If you are the intern assigned to the task, explain why these factors are vital to the procedure and determine their effect on the sensitivity of the test. Factors to Consider Importance Effect 1. Tonicity of the suspending saline solution 2. Overfilling of the tube 3. Proper washing of red cells 4. Too heavy or too diluted red cell suspensionBradford Assay Fill in the average A595 and A595 of sample minus A595 of blank. Show some sample computation. Concentration (micrograms/ml) A595 - trial 1 A595 - trial 2 A595 - trial 3 average A595 A595 of sample minus A595 of blank 0 1.501 1.446 1.447 2 1.624 1.558 1.559 5 1.731 1.749 1.712 10 1.901 1.838 1.892 15 2.161 2.108 2.228 18 2.231 2.277 2.319
- . Throughout downstream processing, various analytical methods must be used to evaluate the effectiveness of unit operations. Provide a method or methods (if more than one is required) for each scenario. Quick determination of the concentration of a purified sample of monoclonal antibody. Determine the concentration of monoclonal antibody in clarified extract. Study aggregation of a protein product without disruption of tertiary protein structure. Characterize phenolics (secondary metabolites and impurities produced by green plant tissue) by identifying phenolic species and relative concentrations.The Nicotinamide Adenine Dinucleotide (NAD) Assay (SIGMA Kit MAKO37) requires preparation of a Standard curve: the first time the blanks are run. each time the assay is run. the first time the assay is run. each time the blank is run.Briefly outline &/or sketch the premise of the transwell assay: